FDA-Device2024-08-28Class II
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Stryker Sustainability Solutions
Hazard
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
Sold states
US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
Affected count
38,850
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2689-2024Don't want to check this manually?
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